Trials / Unknown
UnknownNCT03973632
Pharmacokinetic Study of SH-1028 Tablets in Healthy Subjects Under Fasting and Fed Conditions
A Phase I, Open-label, Single-center, Crossover Design of Food-effect Study of SH-1028 Tablets in Healthy Subjects
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the food-effect of SH-1028 Tablets by pharmacokinetics in healthy subjects under fasting and fed conditions.
Detailed description
By analyzing safety and pharmacokinetics of SH-1028 Tablets in healthy subjects, pharmacokinetic characteristic will be evaluated mainly under fasting and fed conditions.Safety including AE/SAE is also a significant secondary objective.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SH-1028 Tablets | 200mg of SH-1028 Tablets, orally once every cycle. |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2019-06-04
- Last updated
- 2019-06-04
Source: ClinicalTrials.gov record NCT03973632. Inclusion in this directory is not an endorsement.